The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Endocyte.
| Device ID | K843941 |
| 510k Number | K843941 |
| Device Name: | ENDOCYTE |
| Classification | Brush, Endometrial |
| Applicant | GYNECO, INC. 12 MINNEAKONING RD. Flemington, NJ 08822 |
| Contact | Jeanine C Vigeant |
| Correspondent | Jeanine C Vigeant GYNECO, INC. 12 MINNEAKONING RD. Flemington, NJ 08822 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1985-02-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOCYTE 86152798 4813625 Live/Registered |
ENDOCYTE, INC 2013-12-26 |
![]() ENDOCYTE 85306842 4412916 Live/Registered |
Endocyte, Inc. 2011-04-28 |
![]() ENDOCYTE 74580945 1980224 Dead/Cancelled |
SHEAHON, JOHN A. 1994-09-30 |